The Federal Trade Commission is hosting a roundtable entitled "Competition Issues Involving Follow-On Biologic Drugs," Friday, November 21, at its headquarters in Washington. Speakers include industry leaders, government officials, outside counsel and others.
The agenda includes the following presentations:
- Welcoming remarks, FTC Commissioner Pamela Jones Harbour
- Opening remarks, Rachel Behrman, FDA: "How Do Biologic Drugs Differ from Small Molecule Drugs?"
- "Likely Market Effects of Follow-On Biologic Drug Competition," a panel discussion moderated by Michael Wroblewski and Elizabeth Jex, FTC
- "Likely Competitive Effects of Reference Product Regulatory Exclusivity," moderated by Michael Wroblewski and Christopher Garmon, FTC
- "Biotechnology Patent Issues," moderated by Suzanne Michel and Suzanne Drennon, FTC
- "Likely Competitive Effects of Follow-On Biologic Regulatory Incentives," moderated by Michael Wroblewski and Elizabeth Jex, FTC
- "Patent Dispute Resolution Processes," moderated by Michael Wroblewski and Suzanne Drennon, FTC
In advance of the roundtable, over a dozen organizations have submitted comments to the FTC, including BIO, GPhA, and PhRMA.
A live webcast of the event will be offered. For more information, please visit the FTC website.